Medical devices, such as medical devices for diagnostic imaging methods or devices within the framework of a colonoscopy, laboratory devices, ultrasound devices, magnetic resonance tomographs or other medical imaging devices for example, are currently controlled as a rule by software and comprise an operating system or a specific layer of an information technology infrastructure which serves as a distribution platform for application-related services (e.g. middleware such as CORBA, .NET or RPC).
In the prior art a three-part arrangement is provided with respect to the underlying systems:
First of all there is the manufacturer of the operating system or of the respective middleware, who usually markets commercial software products. Secondly there is the manufacturer of medical devices (Siemens, GE etc.), who manufactures the devices and equips with software based on the operating system and supplies them to clinical facilities. Thirdly there are the clinical facilities (hospitals, medical practices etc.), which then use the medical devices.
Because of generally legally-based regulations (e.g. in the USA: FDA, Food and Drug Administration) it is necessary for the medical devices in use to be constantly monitored for compliance with security regulations. To this end it is necessary for it always to be ensured that the newest software version of the operating system is uploaded to the device. For this purpose there is provision for the operating system manufacturer to create and deliver so-called patches, i.e. corrected versions of the software. These patch deliveries must then be validated by the device manufacturer. Previously the operating system manufacturer delivered the patches to the device manufacturer, who validated said packages for reliability. Only after the reliability of the patches could be tested could the patch be delivered to the medical facility (e.g. hospital) which generally leads to considerable delays. Disadvantageously this patching was done manually by system engineers working for the manufacturer of the medical technology devices.
After manual checking the device manufacturer was obliged to inform all customers about a new patch and to issue these to the customers (i.e. hospitals). A significant disadvantage of the previous method is thus its very considerable duration and the involvement of different institutions (which in its turn brings with it an additional requirement for exchange of data). After issuing of the patches it was necessary to initially wait for the device manufacturer to validate the patch. Furthermore there had to be a wait for the device manufacturer to pass on the patch to its customers, who then send a manual check and confirmation signal to the manufacturer, who subsequently, especially in the case of an error, could possibly in their turn inform the operating system manufacturer. It goes without saying that time delays result here when a delay occurs in an element of the aforementioned chain.